Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 16, 2022 | Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-14... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN TH... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, RE... | impaired functionality of the release liner | Class II | ConvaTec, Inc |
| Aug 16, 2022 | Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; R... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RP... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part N... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Numbe... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Referen... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part N... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, RE... | impaired functionality of the release liner | Class II | ConvaTec, Inc |
| Aug 16, 2022 | Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF ... | impaired functionality of the release liner | Class II | ConvaTec, Inc |
| Aug 16, 2022 | Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN ... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Pa... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 12, 2022 | SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Ba... | Potential presence of residual adhesive material on the mesh surface. | Class II | Chamberlain Technologies LLC |
| Aug 12, 2022 | Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION ... | An out of specification component preventing the blue retention ring from keeping the rotation kn... | Class II | Olympus Corporation of the Americas |
| Aug 12, 2022 | COVID Test Kit Nonsterile | Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 dev... | Class II | American Contract Systems, Inc. |
| Aug 12, 2022 | Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION ... | An out of specification component preventing the blue retention ring from keeping the rotation kn... | Class II | Olympus Corporation of the Americas |
| Aug 12, 2022 | Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mob... | Due to un-commanded movement of mobile x-ray unit. | Class II | SEDECAL SA |
| Aug 12, 2022 | SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number... | Potential presence of residual adhesive material on the mesh surface. | Class II | Chamberlain Technologies LLC |
| Aug 12, 2022 | EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component. | Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner impl... | Class II | Encore Medical, LP |
| Aug 12, 2022 | SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Ca... | Potential presence of residual adhesive material on the mesh surface. | Class II | Chamberlain Technologies LLC |
| Aug 12, 2022 | Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION ... | An out of specification component preventing the blue retention ring from keeping the rotation kn... | Class II | Olympus Corporation of the Americas |
| Aug 12, 2022 | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark... | There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the p... | Class II | CooperSurgical, Inc. |
| Aug 12, 2022 | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark... | There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the p... | Class II | CooperSurgical, Inc. |
| Aug 12, 2022 | SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog ... | Potential presence of residual adhesive material on the mesh surface. | Class II | Chamberlain Technologies LLC |
| Aug 12, 2022 | EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Or... | Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner impl... | Class II | Encore Medical, LP |
| Aug 12, 2022 | DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors | Procedure packs contained a recalled product. | Class II | DeRoyal Industries Inc |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI)... | An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunog... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Number... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Number... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Number... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 10, 2022 | VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55... | OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimens... | Class II | Angiodynamics, Inc. |
| Aug 10, 2022 | Artis pheno- Model No. 10849000 | Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 10, 2022 | Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis... | Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and... | Class II | Siemens Medical Solutions USA, Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.